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Study of Efficacy and Safety of Seroquel (Quetiapine Fumarate) as Mono-Therapy for Acute Schizophrenic

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Quetiapine Fumarate (Seroquel)
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Provision of written informed consent for study participation before initiation of any study related procedures, signed by the patient's legal guardian
  • Female and/or male, aged between 18 and 60 years (inclusive)
  • Is hospitalised in a psychiatric unit with an acute episode of schizophrenia defined by CCMD-3 criteria as one of the following: [20.1] paranoid schizophrenia, [20.2] hebephrenic schizophrenia, [20.3] catatonic schizophrenia, [20.5] undifferentiated schizophrenia

Exclusion Criteria:

  • CCMD-3 diagnosis of mental retardation
  • Psychosis judged to be the direct physiological effect of an abused medication or substance

Sites / Locations

  • Research Site
  • Research Site
  • Research SIte
  • Research Site
  • Research Site
  • Research Site
  • Research Site
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Outcomes

Primary Outcome Measures

Change from baseline in PANSS total score at Day 56 (LOCF)

Secondary Outcome Measures

Change from baseline in PANSS positive scale score at Day 56 (LOCF)
Change from baseline in PANSS negative scale score at Day 56 (LOCF)
Change from baseline in PANSS EC score at day 56 ,
Change from baseline in MADRS total score at Day 56. etc

Full Information

First Posted
January 29, 2007
Last Updated
March 24, 2009
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00428350
Brief Title
Study of Efficacy and Safety of Seroquel (Quetiapine Fumarate) as Mono-Therapy for Acute Schizophrenic
Official Title
A 24-Week, Multi-Centre, Open-Label, Single-Arm, Phase IV Study of the Efficacy and Safety of Seroquel (Quetiapine Fumarate) With Daily Dose 600mg-750mg as Mono-Therapy in the Treatment of Acute Schizophrenic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
The primary objective of the study is to evaluate the efficacy of quetiapine fumarate (Seroquel) with daily dose 600mg-750mg used as mono-therapy in the treatment of acute schizophrenic patients by evaluation of the change from baseline in PANSS total score at Day 56 using the last observation carried forward (LOCF) method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Quetiapine Fumarate (Seroquel)
Primary Outcome Measure Information:
Title
Change from baseline in PANSS total score at Day 56 (LOCF)
Secondary Outcome Measure Information:
Title
Change from baseline in PANSS positive scale score at Day 56 (LOCF)
Title
Change from baseline in PANSS negative scale score at Day 56 (LOCF)
Title
Change from baseline in PANSS EC score at day 56 ,
Title
Change from baseline in MADRS total score at Day 56. etc

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of written informed consent for study participation before initiation of any study related procedures, signed by the patient's legal guardian Female and/or male, aged between 18 and 60 years (inclusive) Is hospitalised in a psychiatric unit with an acute episode of schizophrenia defined by CCMD-3 criteria as one of the following: [20.1] paranoid schizophrenia, [20.2] hebephrenic schizophrenia, [20.3] catatonic schizophrenia, [20.5] undifferentiated schizophrenia Exclusion Criteria: CCMD-3 diagnosis of mental retardation Psychosis judged to be the direct physiological effect of an abused medication or substance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Zhu, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gang Wang, MD
Organizational Affiliation
Beijing An Ding hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Research Site
City
Harbin
State/Province
Heilongjiang
Country
China
Facility Name
Research SIte
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Research Site
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Research Site
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Research Site
City
Kunming
State/Province
Yunnan
Country
China
Facility Name
Research Site
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Research Site
City
Huzhou
State/Province
Zhejiang
Country
China
Facility Name
Research Site
City
Beijing
Country
China

12. IPD Sharing Statement

Learn more about this trial

Study of Efficacy and Safety of Seroquel (Quetiapine Fumarate) as Mono-Therapy for Acute Schizophrenic

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